Clearance Summary
SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS received FDA 510(k) clearance under submission number K934817, sponsored by Surgical Design Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-06-17.
- Submission: K934817
- Applicant / Sponsor: Surgical Design Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5550
- Decision date: 1994-06-17
Classification & Regulation
This clearance is catalogued under FDA product code FNM and 21 CFR 880.5550, within the General Hospital review panel as a Class II device.